Kurt Stickley
@kurtstickley
Executive quality leader driving FDA/GMP compliance and successful audits for dietary supplements and cosmetics.
United StatesWhat I'm looking for
I’m an executive quality leader with deep, applied knowledge of FDA regulatory and GMP guidance for Active Pharmaceutical Ingredients (APIs), dietary supplements, and cosmetics. I’ve led and managed QA, QC, R&D, and sanitation functions, directly partnering with customers, suppliers, and regulatory agencies to protect product quality end-to-end.
I lead quality operations for manufacturers producing 250+ to 300+ SKU/year, overseeing everything from raw material receipt through manufacturing, filling, packaging, and delivery. I’ve successfully led 5 FDA audits, owned QMS and HACCP/food defense programs (including PCQI/FSPCA training), handled CAPA, deviations, OOS/OOT, and root-cause investigations, and guided teams through ISO/NSF/USDA Organic compliance—while continuously improving throughput, stability programs, and quality testing efficiency.
Experience
Work history, roles, and key accomplishments
Vice President Quality
Celmark International
Jan 2023 - Jan 2025 (2 years)
Led QA, QC, microbiology, and documentation departments and set quality policy for a manufacturer producing 300+ dietary supplement and cosmetic SKUs annually. Oversaw quality across manufacturing/filling/packaging, managed audits (FDA, USDA, Florida Dept. of Agriculture, NSF), and led CAPA/deviations and customer complaint response.
Vice President Quality & Research
ASEA Global
Jan 2019 - Jan 2023 (4 years)
Increased throughput for the ASEA Redox Supplement (ARS) product 4-fold, from 8 to 32 batches per week, improving product quality and reducing labor and footprint. Built and ran the company QMS, implemented stability programs, wrote internal HACCP plans, and interfaced with FDA/USDA and third-party auditors.
Director of Quality Assurance
Organic Technologies
Jan 2009 - Jan 2019 (10 years)
Improved overall QMS and cGMP functions for dietary products, coordinating with FDA/USDA and internal engineering/R&D to ensure seamless operations. Directed method development oversight, HACCP plan and stability study preparation, supply chain audits, and end-to-end CAPA/root-cause investigations to meet/ exceed industry standards.
Managed global chemical supply by partnering with contract research organizations (CROs) supporting discovery chemists, from request intake through delivery. Tracked CRO productivity/timeliness and removed friction between CROs and internal teams to keep research activities on schedule.
Led laboratory technicians and collaborated across quality assurance and engineering to improve and support plant processes. Developed a new commercial Zoloft (sertraline HCl) process over 5 years and supported technical project collaborations internally and with external partners.
Research Scientist
Organic Technologies
Jan 1996 - Jan 1998 (2 years)
Developed, scaled up, and optimized syntheses of natural flavors, specialty chemicals, and pharmaceutical intermediates, evaluating reaction sequences for cost, safety, and environmental impact. Supported advancement of known and new syntheses to improve practical utility for manufacturing needs.
Education
Degrees, certifications, and relevant coursework
Vanderbilt University
Ph.D., Organic Chemistry
Earned a Ph.D. in Organic Chemistry from Vanderbilt University in Nashville, Tennessee.
Vanderbilt University
M.S., Organic Chemistry
Earned an M.S. in Organic Chemistry from Vanderbilt University in Nashville, Tennessee.
Grove City College
Bachelor of Science, Chemistry
Earned a B.S. in Chemistry from Grove City College in Grove City, Pennsylvania.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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